MAYFIELD® A1051Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780267553), received between Feb 4, 2022 and Sep 5, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20153889 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2024-00106 3004608878-2024-00107 3004608878-2024-00108. A FACILITY REPORTED THAT FOUR INCIDENCES OF PRESSURE INJURY OCCURRED AFTER USING THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) AND THE MAYFIELD PEDIATRIC HORSESHOE HEADREST (A1051). IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY; HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONALLY, THE FACILITY HAS INDICATED THERE WAS NO MALFUNCTION OF THE DEVICE AND IS PERFORMING A MULTIFACTORIAL ROOT CAUSE ANALYSIS.

  Patient problems: Spinal Cord Injury

  MAUDE report 20153887 ↗
• MalfunctionJan 2, 2024Device Slipped; Device Slipped

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2023-00241: A FACILITY REPORTED THAT THE MAYFIELD MODIFIED SKULL CLAMP (A1059) WAS BEING USED FOR CRANIAL STABILIZATION PROCEDURE, AND A SLIP OCCURRED. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428697 ↗
• MalfunctionDec 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPORTED THAT THE LEFT AND RIGHT SIDES OF THE MAYFIELD PEDIATRIC HORSESHOE HEADREST (A1051), DID NOT STAY TOGETHER EVEN WITH SCREW TIGHTENED DOWN AS HARD AS POSSIBLE. DURING A CASE, THE HEADREST FAILED TO STAY LOCKED, CAUSING THE BABY'S HEAD TO SLIP AS THE TWO SIDES SEPARATED. FORTUNATELY, THERE WAS NO INJURY, BUT THERE WAS A 5-MINUTE DELAY AS THEY REPLACED IT WITH ANOTHER UNIT THAT DID NOT SLIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388858 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THE MAYFIELD PEDIATRIC HORSESHOE HEADREST (A1051) WAS USED IN AN UNSPECIFIED SURGERY AND THE PATIENT DEVELOPED A PRESSURE ULCER ON THE FACE. THE PATIENT¿S PRESSURE ULCER HAS NOT DISAPPEARED FOR MORE THAN 2 YEARS AND HAS FILED A LAWSUIT AGAINST THE DISTRIBUTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Ulcer

  MAUDE report 13451425 ↗